U.S. patent number 10,940,305 [Application Number 16/108,974] was granted by the patent office on 2021-03-09 for smart small-bore connector device.
This patent grant is currently assigned to Becton, Dickinson and Company. The grantee listed for this patent is Becton, Dickinson and Company. Invention is credited to S. Ray Isaacson.
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United States Patent |
10,940,305 |
Isaacson |
March 9, 2021 |
Smart small-bore connector device
Abstract
A connector device includes a connector. An electrical lead wire
is positioned in the connector. The electrical lead wire is
configured to provide communication between the connector device
and an external device. In certain embodiments, the electrical lead
wire includes a contact point on a surface of the connector for
electrically coupling the connector device to the external device.
In addition to or as an alternative to the electrical lead wire,
the connector device may include an optical coupling or channel in
the connector configured for optical light transmission between the
connector device and the external device.
Inventors: |
Isaacson; S. Ray (Layton,
UT) |
Applicant: |
Name |
City |
State |
Country |
Type |
Becton, Dickinson and Company |
Franklin Lakes |
NJ |
US |
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Assignee: |
Becton, Dickinson and Company
(Franklin Lakes, NJ)
|
Family
ID: |
1000005408327 |
Appl.
No.: |
16/108,974 |
Filed: |
August 22, 2018 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20190070402 A1 |
Mar 7, 2019 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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62554905 |
Sep 6, 2017 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M
39/10 (20130101); A61M 39/12 (20130101); A61M
39/1011 (20130101); A61M 25/0097 (20130101); A61M
2039/1083 (20130101); A61M 25/0014 (20130101); A61M
2039/1022 (20130101) |
Current International
Class: |
A61M
39/00 (20060101); A61M 39/10 (20060101); A61M
39/12 (20060101); A61M 25/00 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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101854853 |
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Oct 2010 |
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CN |
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2009/003138 |
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Dec 2008 |
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WO |
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Primary Examiner: Carpenter; William R
Attorney, Agent or Firm: Kirton & McConkie Metcalf;
Craig Stinger; Kevin
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATION
This application claims the benefit of U.S. Provisional Application
No. 62/554,905, entitled "Smart Small-Bore Connector Device," filed
Sep. 6, 2017, which is hereby incorporated by reference in its
entirety.
Claims
What is claimed is:
1. A catheter assembly, comprising: a catheter having a distal end
and an opposing proximal end, wherein a longitudinal axis extends
between the distal end and the proximal end; and a connector
coupled in fluid communication to the proximal end of the catheter,
the connector comprising: a base extending along the longitudinal
axis and including a flange extending in a perpendicular direction
relative to the longitudinal axis, the base comprising a sensor
assembly having at least one sensor, the at least one sensor
configured to sense one or more environmental characteristics at an
access site and generate at least one signal representative of the
one or more environmental characteristics; and an electrical lead
wire operatively coupling the at least one sensor to an external
device, wherein the electrical lead wire terminates at a contact
point molded into or formed on a distally-facing surface of the
flange, wherein the contact point is configured to transmit the at
least one signal received from the at least one sensor to the
external device.
2. The catheter assembly of claim 1, wherein the one or more
environmental characteristics includes a temperature within a body
lumen, a blood pressure within the body lumen, a blood glucose
level, a sodium level, a potassium level, an indication of
pregnancy, a drug concentration level, a white blood cell count,
different markers, proteins, and/or chemicals in the patient's
blood stream, or any combination thereof.
3. The catheter assembly of claim 1, wherein the electrical lead
wire is one of molded in the base or coupled to a surface of the
base.
4. The catheter assembly of claim 1, wherein the at least one
sensor comprises a temperature sensor, a sensor that senses a
chemical within a patient's blood, a sensor that senses a marker in
the patient's blood, a sensor that senses a protein in the
patient's blood, or any combination thereof.
5. The catheter assembly of claim 1, comprising a plurality of
electrical lead wires forming an array of electrical lead wires
arranged in a parallel configuration, each electrical lead wire of
the array of electrical lead wires embedded within the connector,
wherein the contact point is configured to facilitate transmission
of signals between the connector and the external device.
6. The catheter assembly of claim 5, further comprising an
additional plurality of electrical lead wires forming a second
array of electrical lead wires arranged in a parallel configuration
and embedded within the connector, each electrical lead wire of the
second array of electrical lead wires terminating at a second
contact point on the base.
7. The catheter assembly of claim 5, wherein the contact point is
formed through a cylindrical wall of the connector, molded into the
cylindrical wall, or formed on an outer surface of the cylindrical
wall.
8. The catheter assembly of claim 5, wherein the array of
electrical lead wires forms a cylindrical ring positioned about an
outer surface of a cylindrical wall of the connector.
9. A catheter assembly, comprising: a catheter having a distal end
and an opposing proximal end, a longitudinal axis extending between
the distal end and the proximal end, and a cannula extending along
the longitudinal axis from the distal end toward the proximal end;
a connector coupled in fluid communication with the catheter, the
connector configured to provide signal communication between the
catheter assembly and an external device, the connector comprising:
a base extending along the longitudinal axis and having a flange
extending in a perpendicular direction relative to the longitudinal
axis, the flange forming threads; a sensor assembly coupled to the
base, the sensor assembly configured to sense one or more
environmental characteristics at an access site and generate at
least one signal representative of the one or more environmental
characteristics; and a coupling disposed on a distally-facing
surface of the flange, the coupling configured to operatively
couple the connector to the external device, the coupling
configured to transmit at least one of a data signal and a command
signal between the sensor assembly and the external device.
10. The catheter assembly of claim 9, wherein the coupling
comprises one of more of the following: an electrical coupling and
an optical coupling.
11. The catheter assembly of claim 9, wherein the coupling
comprises an electrical lead wire electrically coupling an
electrical component of the connector to the external device.
12. The catheter assembly of claim 11, wherein the electrical
component comprises one or more of the following: the sensor
assembly, an electronic module, circuitry, a microcontroller, or a
circuit board.
13. The catheter assembly of claim 11, wherein at least a portion
of the electrical lead wire is molded onto or molded in the
connector.
14. The catheter assembly of claim 13, wherein the electrical lead
wire extends along a surface of a wall of the connector or is
embedded within at least a portion of a length of the wall between
a distal end and an opposing proximal end of the connector.
15. The catheter assembly of claim 9, wherein the coupling
comprises a plurality of electrical lead wires forming an array of
electrical lead wires arranged in a parallel configuration, each
electrical lead wire of the array of electrical lead wires
terminating at a contact point on the base, the contact point
configured to facilitate transmission of signals between the sensor
assembly and the external device.
16. The catheter assembly of claim 15, further comprising an
additional plurality of electrical lead wires forming a second
array of electrical lead wires arranged in a parallel
configuration, each electrical lead wire of the second array of
electrical lead wires terminating at a second contact point on the
base, the second contact point configured to facilitate
transmission of signals between the sensor assembly and the
external device.
17. The catheter assembly of claim 15, wherein the contact point is
formed through a cylindrical wall of the connector, molded into the
cylindrical wall, or formed on a surface of the cylindrical
wall.
18. The catheter assembly of claim 15, wherein the contact point
forms a cylindrical ring positioned about an outer surface of a
cylindrical wall of the base.
19. The catheter assembly of claim 15, wherein the distally-facing
surface of the flange comprises at least one end of the
threads.
20. The catheter assembly of claim 9, wherein the coupling
comprises an optical coupling in the connector, the optical
coupling configured for optical light transmission between the
connector and the external device.
Description
TECHNICAL FIELD
The present disclosure is directed to small-bore connector devices
for liquids and gases. More specifically, the present disclosure is
directed to smart small-bore devices for healthcare applications
having a fitting or connection that includes one or more electrical
lead wires and one or more corresponding electrical contacts to
electrically couple the smart small-bore connector device with an
external device, such as a delivery device and/or a monitoring
device.
BACKGROUND
Luer fittings or connections are used extensively in medical and
life sciences applications. Conventional Luer fittings are
typically small-bore, leak-proof couplings used to couple tubing
and equipment for the transfer of fluids and gases, for
example.
Conventional Luer fittings include slip Luer fittings and Luer lock
fittings. The specifications and performance of these fittings are
covered by International Standard ISO 80369 entitled "Small-bore
connectors for liquids and gases in healthcare applications." The
slip Luer fittings simply conform to Luer taper dimensions and are
pressed together and held by friction, and the Luer lock fittings
include a twist-lock mechanism to hold a hypodermic needle safely
in place, for example. The Luer lock fitting allows the needle to
be coupled and removed from a syringe, minimizing a risk that the
needle slips off the syringe and/or that the syringe tip breaks.
The cooperating slip Luer fittings slip together to form a seal.
Cooperating Luer lock fittings, on the other hand, have
interlocking threads to maintain the leak-proof coupling between
the needle and the syringe. One portion of the Luer lock fitting
(e.g., the syringe tip) has a housing with external threads, while
the cooperating portion of the Luer lock fitting (e.g., the base of
the needle) has a housing with internal threads. These threads urge
the two portions together to provide a leak-proof coupling that can
be easily disengaged.
Luer fittings or connections are widely used in laboratories,
medical devices and intervention therapies. Examples of Luer
fittings include, without limitation, intravenous catheters,
feeding tubes, ventilators, and the common hypodermic syringe. Luer
fittings are available in a variety of materials, such as nylon,
polycarbonate, polypropylene, polyether ether ketone (PEEK), and
stainless steel, for example.
BRIEF SUMMARY OF SOME EXAMPLE EMBODIMENTS
In one aspect, a small-bore connector device includes a plurality
of conductive elements, such as electrical lead wires, positioned
in or insert molded into at least a portion of the small-bore
connector device, e.g., at an adapter or base of the small-bore
connector device. Each conductive element includes a contact point
on a surface of the small-bore connector device and coupled to a
respective electrical lead wire. For example, the contact point may
be positioned on an outer surface of the base or on a surface of a
flange at the proximal end of the small-bore connector device. The
conductive elements may have any suitable number of contact points.
The one or more electrical lead wires electrically couple, e.g., in
signal communication, the small-bore connector device and, in
certain embodiments, a medical device, component, or instrument
operatively coupled to the small-bore connector device, to an
external device, such as a monitoring device and/or delivery
device.
In another aspect, a small-bore connector device includes one or
more suitable optical connections, e.g., one or more optical
fibers, formed or molded in the small-bore connector device for
optical light transmission (fiber optic transmission) between the
small-bore connector device and an external device, such as a
monitoring device and/or delivery device. In certain embodiments,
this feature is molded in a clear material to provide a fiber optic
transmission line or cable without requiring additional parts or
components. Additionally or alternatively, one or more data
connections, similar to a TOS-LINK.RTM. audio transmission cable,
is positioned or molded in the small-bore connector device for data
transmission through the small-bore connector device.
In another aspect, a catheter assembly includes a catheter having a
distal end and an opposing proximal end. A connector is coupled in
fluid communication to the proximal end of the catheter. The
connector includes a base including a sensor assembly having at
least one sensor. The at least one sensor is configured to sense
one or more environmental characteristics at an access site and
generate at least one signal representative of the one or more
environmental characteristics. An electrical lead wire operatively
couples the at least one sensor to an external device. The
electrical lead wire is configured to transmit the at least one
signal received from the at least one sensor to the external
device.
In another aspect, a catheter assembly includes a catheter having a
distal end and an opposing proximal end, and a cannula extending
from distal end toward proximal end. A connector is coupled in
fluid communication with the catheter. The connector is configured
to provide electrical communication between the catheter assembly
and an external device. The connector includes a base having a
flange forming threads. A sensor assembly is coupled to the base.
The sensor assembly is configured to sense one or more
environmental characteristics at an access site and generate at
least one signal representative of the one or more environmental
characteristics. A coupling is configured to operatively couple the
connector to the external device. The coupling is configured to
transmit at least one of a data signal and a command signal between
the sensor assembly and the external device.
In another aspect, a connector device includes a connector
configured to provide electrical communication between the
connector device and an external device. The connector includes a
base having a flange forming threads. A sensor is coupled to the
base. The sensor is configured to sense an environmental
characteristic at an access site and generate a signal
representative of the environmental characteristic. A coupling is
configured to operatively couple the connector to the external
device. The coupling is configured to transmit a signal between the
sensor and the external device.
BRIEF DESCRIPTION OF THE DRAWINGS
FIGS. 1-3 are perspective side views of example small-bore
connector devices with alternative contact points, contact
positions, and/or contact locations;
FIGS. 4 and 5 are perspective side views of example small-bore
connector devices including insert molded electrical connection
elements that terminate on a surface of the small-bore connector
device; and
FIG. 6 is a partial perspective side view of an example small-bore
connector device including an optical (fiber optic) transmission
line insert molded into the small-bore connector device.
DETAILED DESCRIPTION
Various embodiments are described below with reference to the
drawings in which like elements generally are referred to by like
numerals. The relationship and functioning of the various elements
of the embodiments may better be understood by reference to the
following detailed description. However, embodiments are not
limited to those illustrated in the drawings. It should be
understood that the drawings are not necessarily to scale, and in
certain instances details may have been omitted that are not
necessary for an understanding of embodiments disclosed herein,
such as--for example--conventional fabrication and assembly.
The invention is defined by the claims, may be embodied in many
different forms, and should not be construed as limited to the
embodiments set forth herein; rather, these embodiments are
provided so that this disclosure will be thorough and complete, and
will fully convey enabling disclosure to those skilled in the art.
As used in this specification and the claims, the singular forms
"a," "an," and "the" include plural referents unless the context
clearly dictates otherwise. Reference herein to any industry
standards (e.g., ASTM, ANSI, IEEE, ISO standards) is defined as
complying with the currently published standards as of the original
filing date of this disclosure concerning the units, measurements,
and testing criteria communicated by those standards unless
expressly otherwise defined herein. The terms "proximal" and
"distal" are used herein in the common usage sense where they refer
respectively to a handle/doctor-end of a device or related object
and a tool/patient-end of a device or related object. The terms
"about," "substantially," "generally," and other terms of degree,
when used with reference to any volume, dimension, proportion, or
other quantitative or qualitative value, are intended to
communicate a definite and identifiable value within the standard
parameters that would be understood by one of skill in the art
(equivalent to a medical device engineer with experience in this
field), and should be interpreted to include at least any legal
equivalents, minor but functionally-insignificant variants,
standard manufacturing tolerances, and including at least
mathematically significant figures (although not required to be as
broad as the largest range thereof).
In example embodiments, previously unused space on a small-bore
fitting or connection, such as a small-bore connector device, is
utilized to facilitate electrical communication, e.g., power and/or
signal communication, between a suitable upstream source, such as a
therapy infusate source, and the small-bore fitting or connection
used for any suitable type of patient access. The example
small-bore connector device is suitable for use in infusion
therapy, for Peripherally Inserted Central Catheter (PICC) lines,
shunts, and ports, for example. The small-bore fitting or
connection can be used on needleless connectors or any device that
utilizes a small-bore compatible fitting or connection for fluid
flow or fluid communication. The example small-bore connector
devices provide a communication device that can link in a closed
loop the inserted medical device with any type of delivery or
information system via an electrical and data connection built into
the small-bore connector device. In example embodiments, the
small-bore fittings or connections include communication devices in
the defined space of the small-bore fitting or connection to
provide power and/or data transmission into and/or out of the
connection through the small-bore fitting or connection, and
feedback from the distal side back to the proximal side. The
example small-bore connectors described herein satisfy the
requirements of International Standards ISO 80369 for passage of
liquids and gases in healthcare applications and provide
improvements or enhancements to add advanced functionality to the
standard small-bore connectors satisfying the requirements of ISO
80369. In alternative embodiments, the example small-bore connector
device may be suitable for other applications not associated with
ISO 80369.
A smart small-bore connector device, as described herein, provides
electrical communication, e.g., power and/or signal communication,
between a medical device or instrument at a distal end of the smart
small-bore connector device and an external device, such as a fluid
or medication delivery device and/or a monitoring device, at an
opposing proximal end of the smart small-bore connector device. The
medical device or instrument may include a sensor assembly that
provides valuable sensing data with access to a patient's vein,
artery, or other biological access, for example. Such data may be
representative of one or more environmental characteristics at the
access site including, without limitation, a temperature within a
body lumen, a blood pressure within the body lumen, a blood glucose
level, a sodium level, a potassium level, an indication of
pregnancy, a drug concentration level, a white blood cell count,
different markers, proteins, and/or chemicals in the patient's
blood stream, or any combination thereof.
As described herein, a sensor assembly at the distal end of the
smart small-bore connector device includes a sensor or an array of
sensors positioned within a vein or an artery to directly contact
the patient's blood stream. Each sensor is operatively coupled to
the external device using one or more electrical lead wires that
are molded in the smart small-bore connector device or coupled to
an outside surface or an inside surface of the smart small-bore
connector device, for example. In example embodiments, the external
device at the proximal end of the smart small-bore connector device
is configured with one or more of a variety of electronic and/or
communication components to provide power, data transmission, data
collection, and/or data analysis capabilities, as well as other
capabilities.
In example embodiments, the sensor assembly is configured to sense
one or more environmental characteristics within or related to a
patient's biological functions including blood or blood stream and
generate and transmit one or more signals representative of the one
or more environmental characteristics to the external device via
the one or more electrical lead wires of the smart small-bore
connector device. For example, in example embodiments, the sensor
assembly includes one or more sensors, e.g., one sensor or a
plurality of sensors. Each sensor of the sensor assembly is
configured to measure one or more environmental characteristics,
such as described above. Further, the sensor assembly may include
one or more particular sensors including, without limitation, a
temperature sensor, a sensor that senses a chemical within a
patient's blood, a sensor that senses a marker in the patient's
blood, a sensor that senses a protein in the patient's blood, or
any combination thereof.
In alternative example embodiments, a wire configuration including
one or more electrical lead wires may be operatively coupled to the
external device to provide suitable communication protocols, e.g.,
USB level communication having four electrical lead wires, which
can enable a wide range of sensors, data rates and/or data types on
a well-defined BUS. Other suitable communication protocols include,
for example, simple plugin, Wi-Fi, Bluetooth.RTM. wireless
technology, a universal serial bus connector, Radio Frequency
Identification (RFID), Near Field Communication (NCF, a derivative
of RFID), and self-contained displays.
Referring now to the figures, and initially to FIGS. 1-3, an
example catheter 10 has a distal end 12 and an opposing proximal
end 14. Catheter 10 may include a cannula 16 extending from distal
end 12 toward opposing proximal end 14 of catheter 10 in certain
example embodiments. Catheter 10 forms or defines a lumen 18
extending between distal end 12 and proximal end 14 of catheter 10.
In example embodiments, catheter 10 is configured to couple to a
cooperating small-bore fitting or connection, tubing, a hub, or
another suitable connection (not shown in FIGS. 1-6) such that
lumen 18 provides a fluid flow path through catheter 10. In example
embodiments, lumen 18 has a suitable diameter or a suitable
cross-sectional dimension to facilitate fluid flow through catheter
10. Additionally or alternatively, lumen 18 may accommodate a
medical device or instrument, such as an obturator, for example,
that is movably positioned within lumen 18.
At proximal end 14, catheter 10 includes an adapter, such as a
small-bore connector 20 shown in FIGS. 1-3, for example. Small-bore
connector 20 is configured to removably couple to any suitable
medical device or component, for example, a cooperating small-bore
fitting, a device, or a medical tubing. The medical device,
component, or tubing may include a cooperating element, such as a
cooperating small-bore connector, to facilitate coupling the
medical device, component, or tubing, for example, to catheter 10.
In the example embodiments shown in FIGS. 1-6, small-bore connector
20 is a small-bore connection. In these embodiments, small-bore
connector 20 includes a twist-lock mechanism 22 to removably couple
small-bore connector 20 to a cooperating small-bore connector
having a cooperating twist-lock mechanism. For example, a base 24
of small-bore connector 20 may have one or more external threads 26
formed on a flange 28 of small-bore connector 20 that interlocks
with a cooperating internal thread of the cooperating small-bore
connector to draw or urge small-bore connector 20 towards the
cooperating small-bore connector to maintain a substantially
leak-proof coupling between small-bore connector 20 and the
cooperating small-bore connector. Small-bore connector 20 can be
easily disengaged from the cooperating small-bore connector by
rotating small-bore connector 20 in an opposite direction with
respect to the cooperating Luer connector to disengage the threads.
In alternative example embodiments, small-bore connector 20 may be
a slip small-bore fitting that is pressed onto the cooperating
small-bore connector.
In example embodiments, small-bore connector 20 includes one or
more couplings including, without limitation, one or more
electrical couplings, one or more optical couplings, and/one or
more resistive couplings. In certain example embodiments, the one
or more electrical couplings electrically couple, e.g., in signal
communication, electric and/or electronic components on and/or
within catheter 10 and/or operatively coupled to catheter 10 to an
external device positioned at proximal end 14 of catheter 10 or
remotely from catheter 10. The external device may include a
delivery device and/or a monitoring device, for example, having one
or more microcontrollers or processors. The one or more electrical
couplings may provide power from a power source, e.g., a battery,
to the electric and/or electronic components of catheter 10. For
example, the one or more electrical couplings may electrically
couple one or more sensors at distal end 12 of catheter 10 or
small-bore connector 20 to the external device at proximal end 14
to transmit data signals and/or command signals between the sensors
and the external device.
Referring further to FIGS. 1-6, catheter 10 includes one or more
electrical lead wires, e.g., a plurality of electrical lead wires
30, namely, electrical lead wires 30.sub.a, 30.sub.b, . . . ,
30.sub.n, 30.sub.n+1. Electrical lead wires 30 electrically couple,
e.g., in signal communication, electrical components associated
with catheter 10 to an external device or component at proximal end
14 of catheter 10, for example. The electrical components may
include one or more sensors, an electronic module, circuitry, a
microcontroller, and/or a circuit board on catheter 10 or
operatively coupled to catheter 10, for example. In example
embodiments, one or more sensors are coupled in signal
communication to an external device, such as a delivery device
and/or a monitoring device, through electrical lead wires 30 to
provide sensing capabilities.
In certain example embodiments, at least a portion of each
electrical lead wire 30 is molded onto or molded in catheter 10,
for example, molded on or within small-bore connector 20. Each
electrical lead wire 30 may extend along a surface of a wall of
catheter 10 or may be embedded or molded within at least a portion
of a length of the catheter wall between distal end 12 and proximal
end 14. As shown in FIGS. 4 and 5, in example embodiments, catheter
10 includes a plurality of electrical lead wires 30.sub.a,
30.sub.b, . . . , 30.sub.n, 30.sub.n+1 forming a first array 32 of
electrical lead wires 30 arranged in a parallel configuration. Each
electrical lead wire 30 is embedded within small-bore connector 20
and terminates at a contact 34 on a proximal surface 36 of flange
28. In certain example embodiments, catheter 10 also includes an
additional plurality of electrical lead wires 30.sub.a, 30.sub.b, .
. . , 30.sub.n, 30.sub.n+1 forming a redundant or second array 40
of electrical lead wires 30 arranged in a parallel configuration
and embedded within small-bore connector 20. Each electrical lead
wire 30 of second array 40 terminates at a contact point 42 on
proximal surface 36 of flange 28. As shown in FIG. 5, in certain
example embodiments, catheter 10 may alternatively or in addition
to first array 32 and/or second array 40 include a third array 44
of electrical lead wires 30.sub.a, 30.sub.b, . . . , 30.sub.n,
30.sub.n+1 arranged in a parallel configuration. Each electrical
lead wire 30 of third array 44 is embedded within small-bore
connector 20 and terminates at a contact point 46 on proximal
surface 36 of flange 28.
Referring again to FIGS. 1-3, contact points 34, 42, and/or 46 can
be positioned at any suitable location on catheter 10. For example,
as shown in FIG. 1, contact points 34 and/or contact points 42 may
be formed through a cylindrical wall 48 of small-bore connector 20,
molded into cylindrical wall 48, or formed on an outer surface of
cylindrical wall 48. Any suitable number of contact points 34, 42
with corresponding electrical lead wires 30 may be present on or
within small-bore connector 20. Contact points 34, 42 may be used
to provide power to an electric or electronic component associated
with catheter 10 and/or a device operatively coupled to catheter
10, as well as facilitate the transmission of signals between
catheter 10 and an external device operatively coupled to catheter
10. Contact points 34, 42 may also be used as a standard USB
connection to operatively couple small-bore connector 20 to an
external device or a cooperating small-bore connector for another
suitable device in certain embodiments. Additionally or
alternatively, as described above, one or more contact points, such
as contact points 46, may be molded into or formed on a surface of
flange 28, e.g., proximal surface 36, or on a surface of one or
more external threads 26.
As shown in FIG. 2, one or more contact points may form a coil or
cylindrical rings 56 positioned about an outer surface of
cylindrical wall 48 to provide contact or interaction with spring
fingers on a cooperating small-bore fitting or connection, for
example. As shown in FIG. 3, one or more contact points, such as
contact points 46, may be molded into or formed on a
distally-facing surface 58 of flange 28 providing for a quick
connect or snap fit to couple electrical lead wires 30 to the
external device.
In an alternative example embodiment as shown in FIG. 6, one or
more suitable optical couplings 60, e.g., one or more optical
fibers, can be built in, e.g., molded in, small-bore connector 20
for optical light transmission (fiber optic transmission) between
small-bore connector 20 and an external device 62, such as a
monitoring device and/or a delivery device. In certain embodiments,
this feature is molded in a clear material to provide a fiber optic
transmission line or cable without requiring additional parts or
components. Additionally or alternatively, one or more data
connections 64, similar to a TOS-LINK.RTM. style audio transmission
cable, can be built in, e.g., molded in, small-bore connector 20
for data transmission between the patient therapy side, e.g.,
small-bore connector 20, and external device 62. Data connections
64 can be created with more specialized optical fiber cables as
needed.
In example embodiments, the external device, e.g., a monitoring
device and/or a delivery device, includes one or more processors
configured to transmit signals to and receive signals from the
sensor assembly. In certain embodiments, a communication module or
circuitry operatively coupled to small-bore connector 20 is
electrically coupled to, e.g., in signal communication with, the
external device for wireless communication with the external device
or an external processor. In these embodiments, the communication
module or circuitry includes a radio frequency identification
transmitter, a near field communication transmitter, a
Bluetooth.RTM. wireless technology transmitter, a universal serial
bus connector, or any suitable combination thereof. The external
device may include one or more processors and one or more
computer-readable media, one or more communication interfaces, and
one or more power sources. The communication interfaces may support
both wired and wireless connection to various networks, such as
cellular networks, radio, Wi-Fi networks, short range networks
(e.g., Bluetooth.RTM. technology), and infrared (IR) networks, for
example.
Depending on the configuration of the external device, the
computer-readable media is an example of computer storage media and
may include volatile and nonvolatile memory. Thus, the
computer-readable media may include, without limitation, RAM, ROM,
EEPROM, flash memory, and/or other memory technology, and/or any
other suitable medium that may be used to store computer-readable
instructions, programs, applications, media items, and/or data
which may be accessed by the external device. The computer-readable
media may be used to store any number of functional components that
are executable on a processor. The external device may have
additional features or functionality. For example, the external
device may also include additional data storage devices (removable
and/or non-removable). The additional data storage media, which may
reside in a control board, may include volatile and nonvolatile,
removable and non-removable media implemented in any method or
technology for storage of information, such as computer readable
instructions, data structures, program modules, or other data. In
addition, some or all of the functionality described as residing
within the external device may reside remotely from the external
device.
Below are several non-limiting, example applications for catheter
10 including small-bore connector 20.
In a first example application, a patient therapy site includes a
small blood glucose sensor. An infusing pump is configured to power
the sensor through two connections on small-bore connector 20, and
send and receive information or data via one or more signals from
the sensor to understand how to properly administer a proper amount
of insulin or another balancing element.
In a second example application, catheter 10 includes a resistive
element in small-bore connector 20 that identifies a size and/or a
gauge for the therapy site. A pump or another suitable therapy
device is configured to deliver a correct flow rate or a maximum
safe flow rate. The resistive value could also indicate a type of
device coupled to catheter 10 at small-bore connector 20; thus,
facilitating the elimination or decrease in procedures and
therapies that might not be compatible with the delivery
mechanism.
In example embodiments described herein, a smart small-bore
connector device includes a small-bore connector and one or more
electrical lead wires in the small-bore connector. The electrical
lead wires are configured to provide power to the smart small-bore
connector device and/or communication between the smart small-bore
connector device and an external or remote device. Each electrical
lead wire includes a contact point on a surface of the small-bore
connector for electrically coupling the smart small-bore connector
device to the external or remote device.
In certain embodiments, the smart small-bore connector device
includes one or more electrical wires used for power transmission
and/or for data transmission. One or more of the electrical wires
may be positioned on a proximal flange of the small-bore connector,
on a distal side or surface of the small-bore connector threads,
ears and/or flange, and/or on the outer diameter a fluid connection
and sealing area of the small-bore connector.
In certain example embodiments, a smart small-bore connector device
includes a small-bore connector and at least one optical channel
that provides a contact or interface point on a surface of the
small-bore connector for optically coupling the smart small-bore
connector device to an external or remote device. In certain
embodiments, the at least one optical channel may be molded into
the mating small-bore connector with a dissimilar material from the
small-bore connector material. The optical channel is molded into
the mating small-bore connector with a fiber optic cable
assembly.
In a third example application, catheter 10 includes an electrical
serial number, and, when first used, catheter 10 is configured to
communicate with the external device to record a date, a time, and
a patient's name, for example. An external database is used to
track a therapy time and/or a replacement time, for example. This
active identification can then be used to prompt healthcare workers
to take appropriate action when alerted, e.g., remove or provide
maintenance of catheter 10 or a medical device or instrument
operatively coupled to catheter 10.
In a fourth example application, small-bore connector 20 is
configured for optical light transmission. In this example
application, small-bore connector 20 includes an optical fiber
molded into small-bore connector 20 to facilitate communication
between catheter 10 and the external device, e.g., a monitoring
device and/or a delivery device.
Those of skill in the art will appreciate that embodiments not
expressly illustrated herein may be practiced within the scope of
the claims, including that features described herein for different
embodiments may be combined with each other and/or with
currently-known or future-developed technologies while remaining
within the scope of the claims. Although specific terms are
employed herein, they are used in a generic and descriptive sense
only and not for purposes of limitation unless specifically defined
by context, usage, or other explicit designation. It is therefore
intended that the foregoing detailed description be regarded as
illustrative rather than limiting. And, it should be understood
that the following claims, including all equivalents, are intended
to define the spirit and scope of this invention. Furthermore, the
advantages described above are not necessarily the only advantages
of the invention, and it is not necessarily expected that all of
the described advantages will be achieved with every embodiment. In
the event of any inconsistent disclosure or definition from the
present application conflicting with any document incorporated by
reference, the disclosure or definition herein shall be deemed to
prevail.
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